FDA Approves Ortho McNeil Janssen's Razadyne ER

Treating mild to moderate dementia (eg, impairment of memory or judgement, abstract thinking, changes in personality) in patients with Alzheimer disease.

Razadyne ER Extended-Release Capsules are a cholinesterase inhibitor. It works by increasing the amount of a certain substance (acetylcholine) in the brain, which may help reduce symptoms of dementia in patients with Alzheimer disease.

The RAZADYNE ER capsules contain a rate-controlling membrane that allows the medication to be released gradually over a 24-hour period. This new formulation contains an immediate and extended release dose that allows for the convenience of once-daily dosing.

"Alzheimer's is an overwhelming diagnosis for the patient, for his or her spouse, for adult children and even for extended family members," said Joanne Koenig Coste, renowned Alzheimer's care pioneer and author of Learning to Speak Alzheimer's. "Anything that may help make treatment more convenient for patients and their family members is always a welcome addition."

In the clinical study, 965 patients were randomly assigned to receive RAZADYNE ER, twice-daily galantamine or placebo. Patients treated with RAZADYNE ER had significant improvement in cognition as measured by the mean change in Alzheimer's Disease Assessment Scale (ADAS-cog/11) scores compared to patients treated with placebo at six months.

What is Razadyne ER/Razadyne?

Razadyne is used in Alzheimer's patients to treat mild to moderate dementia. It is thought to work by boosting levels of the chemical messenger acetylcholine in the brain. (In Alzheimer's disease, the cells that produce acetylcholine slowly deteriorate.)

What is the most important information I should know about Razadyne ER/Razadyne?

The use of Razadyne may cause you to develop a slow heart rate. You should notify your physician if you develop symptoms of dizziness or faintness.

Razadyne may also cause you to develop gastrointestinal symptoms such as nausea, vomiting, diarrhea, a loss of appetite, and weight loss.

While on therapy with Razadyne, it is important to drink an adequate amount of fluids.

It is important to avoid skipping doses of Razadyne. If you miss taking Razadyne for several days, it is important to contact your physician. He or she may have to give you a lower dose of Razadyne, and then gradually increase your dose back to the dose you were originally taking.

If you are planning to undergo surgery, it is important to notify your surgeon that you are on therapy with Razadyne.